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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05896228
Other study ID # 20230227
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 20, 2024
Est. completion date March 1, 2031

Study information

Verified date February 2024
Source University of Miami
Contact Michelle D Armogan
Phone 305-243-7479
Email mda182@med.miami.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators want to find out whether or not giving patients who have relapsed or refractory multiple myeloma (MM) the experimental medication combination iberdomide, carfilzomib, daratumumab, and dexamethasone (Iber-KDd) may produce better results than the current (standard of care) treatments. This study will examine the tolerability and efficacy of this combination therapy for all participants and the ability of this combination therapy to shrink or prevent MM from returning.


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Study Design


Intervention

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Locations

Country Name City State
United States University of Miami Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
Carl Ola Landgren, MD, PhD Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of MRD-negativity: Iber-KDd Combination therapy. The rate of minimal residual disease negativity (MRD-negativity) will be reported as the number of participants achieving MRD-negativity after eight cycles of Iber-KDd combination therapy. MRD-negativity is defined as less than one (<1) residual cancer cell detected in 100,000 cells assessed. Up to 8 months
Secondary Number of Participants Experiencing Treatment-Related Toxicity After Starting Iber-KDd Combination Therapy The safety and tolerability of Iber-KDd combination therapy will be assessed and reported as the number of participants experiencing treatment-related toxicity after start of combination therapy, including treatment-related adverse events (AEs) and serious adverse events (SAEs). AEs and SAEs will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5, per physician discretion. Up to 9 months
Secondary Best Response: Iber-KDd Combination Therapy Best response will be reported as the proportion of participants achieving their greatest response to Iber-KDd combination therapy as follows: Partial response (PR) or better, very good partial response (VGPR) or better, complete response (CR), and stringent complete response (sCR). Response will be assessed using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma. Up to 8 months
Secondary Overall Response Rate (ORR): Iber-KDd Combination Therapy Overall response rate (ORR) is defined as the number of participants achieving partial response (PR), very good partial response (VGFR)m complete response (CR) or stringent complete response (sCR) to Iber-KDd combination therapy. Response will be assessed using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma. Up to 8 months
Secondary Best Response: Iber Monotherapy Best response will be reported as the proportion of participants achieving their greatest response to Iberdomide monotherapy as follows: Partial response (PR) or better, very good partial response (VGPR) or better, complete response (CR), and stringent complete response (sCR). Response will be assessed using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma. Up to 20 months
Secondary Overall Response Rate (ORR): Iber Monotherapy Overall response rate (ORR) is defined as the number of participants achieving partial response (PR), very good partial response (VGFR)m complete response (CR) or stringent complete response (sCR) to Iberdomide monotherapy. Response will be assessed using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma. Up to 20 months
Secondary Duration of Response (DOR): Iber-KDd Combination Therapy Duration of Response (DOR) to Iber-KDd combination therapy will be assessed. Duration of response (DOR) is defined as time from response to progression of disease or death, whichever occurs first. Up to 8 months
Secondary Overall Survival (OS) Overall survival (OS) is defined as the time from date of first dose of study treatment to death from any cause. Up to 5 years
Secondary Progression-Free Survival (PFS) Progression-free survival (PFS) is defined as time from date of first dose of study treatment to time of progression or death, whichever occurs first. Up to 5 years
Secondary Event-Free Survival (EFS) Event-free survival (EFS) is defined as time from date of first dose of study treatment until 1) toxicity requiring removal from study, 2) progression, or 3) death, whichever occurs first. Up to 5 years
Secondary Rate of Sustained MRD-negativity. The rate of sustained minimal residual disease negativity (MRD-negativity) at the completion combination Iber-KDd therapy and 12 cycles of iberdomide monotherapy will be assessed. MRD-negativity is defined as less than one (<1) residual cancer cell detected in 100,000 cells assessed. The number of participants will sustained Response will be assessed using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma. Up to 20 months
Secondary Rate of MRD-negativity: Iberdomide monotherapy. The rate of MRD-negativity as best response will be assessed among participants completing Iberdomide monotherapy. The number of participants with MRD-negativity at the 10^-5 sensitivity will be reported. MRD-negativity is defined as less than one (<1) residual cancer cell detected in 100,000 cells assessed. Response will be assessed using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma. Up to 20 months
Secondary Number of Participants Experiencing Treatment-Related Toxicity After Starting Iberdomide Monotherapy The safety and tolerability of Iber monotherapy will be assessed and reported as the number of participants experiencing treatment-related toxicity after start of monotherapy, including treatment-related adverse events (AEs) and serious adverse events (SAEs). AEs and SAEs will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5, per physician discretion. Up to 21 months
See also
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